NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

The Role of NEUROCUPLE™ as an Alternative to Opioids Following Total Knee Arthroplasty Patients

The goal of this clinical trial is to learn if the NEUROCUPLE device can reduce pain and opioid use after primary unilateral total knee arthroplasty (TKA) in adults.

The main questions it aims to answer are:

• Does the NEUROCUPLE device reduce postoperative pain at rest during the first 24 hours after TKA?
• Does the NEUROCUPLE device reduce opioid consumption during the first 24 hours after TKA?

Researchers will compare the NEUROCUPLE device to a placebo device (identical in appearance but inactive) to see if the device reduces pain and opioid use after surgery.

Participants will:

• Apply the NEUROCUPLE device or placebo device for 7 days following surgery
• Have their pain and opioid use monitored through clinical records and patient reporting
• Report pain at rest and during movement on postoperative Days 2 and 7
• Be assessed for nausea, vomiting, device-related side effects, length of hospital stay, and overall satisfaction

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty Postoperative Pain; Opioid Reduction After TKA
• Intervention / Treatment: Device: NEUROCUPLE™ Patch; Other: Enhanced Recovery After Surgery (ERAS) Standard of Care; Device: Sham patch

• Study Type: Interventional
• Enrollment (Estimated): 274
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques E. Chelly, MD, PhD, MBA; Phone Number: (412)623-6904; Email: ChelJE@anes.upmc.edu
• Study Contact Backup: Name: Dayana Alsamsam, BSPS, MSc; Phone Number: 412-123-4567; Email: alsamsamd@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Shadyside Hospital
      • Contact: Amy Monroe, MPH, MBA; Phone Number: 412-623-6382; Email: monroeal@upmc.edu
      • Contact: Dayana Alsamsam, BSPS, MSc; Email: alsamsamd@upmc.edu
      • Principal Investigator: Jacques E. Chelly, MD, PhD, MBA
    • Pittsburgh, Pennsylvania, United States, 15237
      • UPMC Passavant Hospital
      • Principal Investigator: Jacques E. Chelly, MD, PhD, MBA
    • Pittsburgh, Pennsylvania, United States, 15146
      • UPMC East Hospital
      • Principal Investigator: Jacques E. Chelly, MD, PhD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >18 years of age
• Scheduled for elective primary unilateral TKA

Exclusion Criteria:

• Children (<18 yr.)
• Pregnant women
• Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
• Severe chronic pain condition that requires daily preoperative opioid dependence
• Other concomitant surgery being performed in addition to TKA
• Patients undergoing bilateral TKA
• Patients undergoing knee replacement revision
• Patients with limited mobility (in a wheelchair or requiring a walker)
• Patients who are not returning home after surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEUROCUPLE™ Group; This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.	Device: NEUROCUPLE™ Patch; nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year. The patch will be worn for 7-days; Other: Enhanced Recovery After Surgery (ERAS) Standard of Care; Participants in both arms will receive approved Enhanced Recovery After Surgery (ERAS) multimodal care, including preoperative education and optimization, intraoperative minimally invasive techniques and multimodal analgesia, and postoperative early mobilization, early nutrition, pain control, and monitoring for complications
Sham Comparator: Sham Group; This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.	Other: Enhanced Recovery After Surgery (ERAS) Standard of Care; Participants in both arms will receive approved Enhanced Recovery After Surgery (ERAS) multimodal care, including preoperative education and optimization, intraoperative minimally invasive techniques and multimodal analgesia, and postoperative early mobilization, early nutrition, pain control, and monitoring for complications; Device: Sham patch; Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total opioid consumption, expressed in milligrams of morphine equivalents (MME), during the first 24 hours following surgery. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and, when applicable, the state Prescription Drug Monitoring Program (PDMP). MME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, while higher MME values suggest increased opioid use and potentially greater pain or slower recovery.	0- 24 hours post-surgery
Pain at Rest Using Numerical Rating Scale (NRS)	Pain at rest during the first 24 hours after surgery will be assessed using a Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain) and compared between the NEUROCUPLE™ patch group and the placebo patch group. Higher scores indicate worse pain	0-24 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement	Pain will be assessed using a Numerical Rating Scale (0 = no pain, 10 = worst pain) at rest and during movement on postoperative Days 2 and 7. Higher scores indicate worse pain.	Post-operative at Day 2 and Day 7
Incidence of postoperative nausea and/or vomiting (yes/no)	Incidence and severity of postoperative nausea and vomiting will be recorded over the 7-day postoperative period as (yes/no) and compared between groups.	Postoperative Days 0-7
Postoperative Length of Stay	Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge, will be recorded and compared between groups. Lower length of stay values indicate faster recovery, fewer complications, and earlier readiness for discharge. Higher length of stay values suggest slower recovery, increased complications, or higher postoperative symptom burden.	From the date of surgery until hospital discharge (within the 7-day study period)
Postoperative Adverse Events and Device-Related Side Effects	The incidence of postoperative adverse events, including any events determined to be related to the study device, will be recorded and compared between the treatment groups during the 7-day postoperative period. Lower incidence rates indicate fewer complications and a more favorable safety profile, whereas higher incidence rates suggest increased complications, potential device-related issues, or a less favorable safety profile.	Postoperative Days 0-7
Patient Satisfaction	Patient satisfaction with recovery and device use will be assessed on postoperative Day 7 using standardized questionnaires. Scores range from 0 to 10, where 0 indicates the lowest level of satisfaction and 10 indicates the highest.	at Post-operative Day 7
Opioid Consumption	Total opioid consumption, expressed in milligrams of morphine equivalents (MME), will be recorded over the 7-day postoperative period. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and the state Prescription Drug Monitoring Program (PDMP) when applicable. MME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, whereas higher MME values suggest increased opioid use and potentially greater pain or slower recovery.	Post-Operative Day 0- Day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction with recovery and device use will be assessed on postoperative Day 7 using standardized questionnaires. Scores range from 0 to 10, where 0 indicates the lowest level of satisfaction and 10 indicates the highest.	at Post-operative Day 7
Postoperative Adverse Events and Device-Related Side Effects	The incidence of postoperative adverse events, including any events determined to be related to the study device, will be recorded and compared between the treatment groups during the 7-day postoperative period. Lower incidence rates indicate fewer complications and a more favorable safety profile, whereas higher incidence rates suggest increased complications, potential device-related issues, or a less favorable safety profile.	Postoperative Days 0-30 days
Opioid Consumption	Total opioid consumption, expressed in milligrams of morphine equivalents (MME), during the first 24 hours following surgery. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and, when applicable, the state Prescription Drug Monitoring Program (PDMP). MME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, while higher MME values suggest increased opioid use and potentially greater pain or slower recovery.	Post-Operative Day 0- Day 7
Pain at Rest Using Numerical Rating Scale (NRS)	Pain at rest during the first 24 hours after surgery will be assessed using a Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain) and compared between the NEUROCUPLE™ patch group and the placebo patch group. Higher scores indicate worse pain	Post-Operative Day 0- Day 7

Collaborators and Investigators

• Sponsor: Jacques E. Chelly
• Collaborators: nCap Medical
• Investigators: Principal Investigator: Jacques E. Chelly, MD, PhD, MBA, University of Pittsburgh / UPMC; Study Director: Amy Monroe, MPH, MBA, University of Pittsburgh / UPMC

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Total Knee Arthroplasty; Opioid Use; Knee Replacement; Randomized Clinical Trial; TKA; Acute Postoperative Pain; Non opioid Pain Management; NEUROCUPLE Patch
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Health Services Administration; Health Care Quality, Access, and Evaluation; Surgical Procedures, Operative; Quality of Health Care; Quality Indicators, Health Care; Perioperative Care; Standard of Care; Enhanced Recovery After Surgery
• Other Study ID Numbers: STUDY25120065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No